OtherEuropean Union
EU Clinical Trials Regulation (CTR 536/2014)
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC.
Domains
Chapter VIII-XI — Supervision and Transparency
Chapter II — Application and Authorisation
Chapter III — Subject Protection
Chapter V-VII — Safety Reporting and GMP
Compare EU Clinical Trials Regulation (CTR 536/2014)
EU Clinical Trials Regulation (CTR 536/2014) vs ISO 27001:2022View comparison →EU Clinical Trials Regulation (CTR 536/2014) vs SOC 2View comparison →EU Clinical Trials Regulation (CTR 536/2014) vs NIST CSF 2.0View comparison →EU Clinical Trials Regulation (CTR 536/2014) vs GDPRView comparison →EU Clinical Trials Regulation (CTR 536/2014) vs HIPAAView comparison →EU Clinical Trials Regulation (CTR 536/2014) vs PCI DSS 4.0View comparison →
EU Clinical Trials Regulation (CTR 536/2014) by Industry
EU Clinical Trials Regulation (CTR 536/2014) for Healthcare→EU Clinical Trials Regulation (CTR 536/2014) for Financial Services→EU Clinical Trials Regulation (CTR 536/2014) for Technology→EU Clinical Trials Regulation (CTR 536/2014) for Government→EU Clinical Trials Regulation (CTR 536/2014) for Manufacturing→EU Clinical Trials Regulation (CTR 536/2014) for Energy→EU Clinical Trials Regulation (CTR 536/2014) for Retail→EU Clinical Trials Regulation (CTR 536/2014) for Education→
EU Clinical Trials Regulation (CTR 536/2014) by Role
EU Clinical Trials Regulation (CTR 536/2014) for CISOs→EU Clinical Trials Regulation (CTR 536/2014) for Compliance Officers→EU Clinical Trials Regulation (CTR 536/2014) for Risk Managers→EU Clinical Trials Regulation (CTR 536/2014) for IT Directors→EU Clinical Trials Regulation (CTR 536/2014) for DPOs→EU Clinical Trials Regulation (CTR 536/2014) for Auditors→
Frequently Asked Questions
What is EU Clinical Trials Regulation?
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC.
How many controls does EU Clinical Trials Regulation have?
EU Clinical Trials Regulation contains 17 controls organized across 4 domains.
Where does EU Clinical Trials Regulation apply?
EU Clinical Trials Regulation is applicable in European Union. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does EU Clinical Trials Regulation map to?
EU Clinical Trials Regulation has control-to-control mappings with 506 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with EU Clinical Trials Regulation compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
How ready are you for EU Clinical Trials Regulation (CTR 536/2014)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.